Infusion Pumps

ABSTRACT

Ambulatory infusion pumps, pump assemblies, and baseplate assemblies, including cartridges, baseplates, cannulas, inserters, and related components and batteries therefor, as well as component combinations and related methods.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Ser.No. 61/415,830, filed Nov. 20, 2010 and entitled “Infusion Pumps,” whichis incorporated herein by reference in its entirety.

This application claims the benefit of U.S. Provisional Application Ser.No. 61/487,705, filed May 18, 2011 and entitled “Infusion Pumps,” whichis incorporated herein by reference in its entirety.

BACKGROUND

1. Field

The present devices and methods relate generally to ambulatory infusionpumps.

2. Description of the Related Art

Ambulatory infusion pumps (also referred to herein simply as “infusionpumps”) are relatively small, at least substantially self-containeddevices that are used to introduce drugs and other infusible substances(collectively “medicament”) into patients' bodies. Some infusion pumpsare configured to be worn on a belt or carried in a clothing pocket.Other infusion pumps are configured to be adhered to skin in patch-likefashion. Infusion pumps are advantageous in that they may be used to,for example, subcutaneously introduce (or “infuse”) medicament on anongoing or even continuous basis outside of a clinical environment.Infusion pumps are also advantageous in that they greatly reduce thefrequency of subcutaneous access events such as needle-based shots. Oneexample of a medicament that may be introduced by an infusion pump is aliquid formulation of insulin. Other exemplary medicaments that may beintroduced by an infusion pump include, but are not limited to, drugsthat treat cancers and drugs that suppress the perception of pain.

Many conventional infusion pumps have improved patient health andquality of life. Nevertheless, the present inventors have determinedthat conventional infusion pumps are susceptible to a wide range ofimprovements. By way of example, but not limitation, the presentinventors have determined that it would be desirable to provide aninfusion pump that is smaller, more accurate and/or provides moreoperational flexibility than conventional infusion pumps.

SUMMARY

A system in accordance with at least one of the present inventionsincludes an infusion pump assembly and a baseplate assembly. Theinfusion pump assembly may include a housing and a rechargeable batteryin the housing. The baseplate assembly may include a baseplate and abaseplate energy supply, and may be configured to be attached to theinfusion pump housing. Energy from the baseplate power supply may betransferred to the rechargeable battery when the baseplate assembly isattached to the housing.

A method in accordance with at least one of the present inventionsincludes the step of securing a baseplate assembly with a baseplateenergy supply to an infusion pump assembly with a rechargeable batterysuch that energy from the baseplate energy supply is transferred to therechargeable battery.

An infusion pump system in accordance with at least one of the presentinventions includes an infusion pump assembly with a plunger pusher anda baseplate assembly with a baseplate and a medicament cartridge,including a barrel defining a reservoir and a plunger movable within thebarrel, on the baseplate. The infusion pump assembly and the baseplateassembly may be configured to be attached to one another in such amanner that the plunger pusher will be aligned with the plunger.

A baseplate assembly in accordance with at least one of the presentinventions includes a baseplate, a medicament cartridge on the baseplatedefining a reservoir, a cannula and a cannula inserter.

The features and attendant advantages of the present inventions willbecome apparent as the inventions become better understood by referenceto the following detailed description when considered in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of exemplary embodiments will be made withreference to the accompanying drawings.

FIG. 1 is an exploded perspective view of an exemplary infusion pump kitincluding an infusion pump assembly and three baseplate assemblies.

FIG. 2A is a schematic view showing use of an exemplary infusion pumpsystem.

FIG. 2B is a schematic view showing use of an exemplary infusion pumpsystem.

FIG. 3 is a perspective view of an exemplary pump assembly.

FIG. 4 is a bottom view of the exemplary pump assembly illustrated inFIG. 3.

FIG. 5 is perspective view of the exemplary pump assembly illustrated inFIG. 3 with a baseplate attached and associated cartridge inserted.

FIG. 6 is a perspective view of an infusion pump assembly being attachedto a battery recharging device.

FIG. 7 is a graph showing recharging temperature during an exemplarybattery recharging method.

FIG. 8 is a flow chart showing an exemplary baseplate assembly removaland replacement method.

FIG. 9 is a front view showing a patient's skin being cleaned.

FIG. 10 is a section view showing the pump assembly attached to theexemplary baseplate assembly, including cartridge, a cannula inserter,and cannula, plus a pull before use plug.

FIG. 11 is a section view showing the system illustrated in FIG. 10 onthe cleaned skin prior to cannula insertion.

FIG. 12 is a section view showing the system illustrated in FIG. 11after cannula insertion.

FIG. 13 is a section view showing the system illustrated in FIG. 12 onthe skin with the cannula inserted and the inserter being removed.

FIG. 14 is a section view showing the system illustrated in FIG. 13dispensing medicament by way of the cannula.

FIG. 15 is a side view of a portion of one of the baseplate assembliesillustrated in FIG. 1.

FIG. 16 is a bottom view of a portion of the pump assembly illustratedin FIG. 1.

FIG. 17 is an exploded perspective view of another exemplary infusionpump system.

DETAILED DESCRIPTION

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

It should also be noted here that the specification describes structuresand methods, mainly in the context of cartridge-based infusion pumps,which are especially well-suited for the subcutaneous delivery of veryhigh concentration insulin (e.g., the U-500 insulin discussed below).Nevertheless, it should be appreciated that the present inventions areapplicable to a wide variety of infusion pumps and medicaments. By wayof example, but not limitation, many of the present inventions are alsoapplicable to infusion pumps that are not cartridge-based (e.g., pumpswith refillable reservoirs and single use pumps). Also, the inventionsmay employ, for fluid displacement, a cartridge with a plunger, a fluiddisplacement device in the form of a plunger pusher, and a drivemechanism that includes a motor, or other fluid displacement devices,regardless of the type of cartridge or reservoir employed, piston pumps(e.g., electromagnet pumps), MEMS pumps, peristaltic pumps and any othersuitable pumps as well as corresponding drive mechanisms. Exemplaryinfusion pumps that include a cartridge with a plunger, a fluiddisplacement device in the form of a plunger pusher, and a drivemechanism are described in U.S. patent application Ser. No. 12/890,207,filed Sep. 24, 2010, which is hereby incorporated by reference in itsentirety. The present inventions are also applicable to medicaments suchas, for example, drugs to mask pain, chemotherapy and other cancerrelated drugs, antibiotics, hormones, GLP-1, Glucagon, various otherdrugs that include large molecules and proteins that may require a highlevel of delivery accuracy, as well as to relatively high concentrationinsulin (i.e., U-200 and above) such as U-500 insulin.

As noted above, some ambulatory infusion pumps are intended to be wornon a belt, carried in a pocket, or otherwise supported within a holderof some kind (referred to collectively as “pocket pumps”). Such infusionpumps transfer fluid from a reservoir to an infusion set by way of anelongate tube. Subcutaneous access may be obtained by way of a cannulain the infusion set. Other ambulatory infusion pumps are intended to beadhered to the skin at the delivery site (sometimes referred to as“patch pumps”). Here, the cannula or other subcutaneous access devicemay extend directly from the infusion device. Given these modes of use,patients typically prefer the pump to be as small as possible so thatthe pump will be more comfortable, less obtrusive, and less visible. Inaddition, patients want a device that is easy and convenient to use.

Exemplary ambulatory infusion systems, which are generally representedby reference numerals 10, 11 and 12 in FIG. 1, include a medicamentcartridge (or “cartridge”) 100, an ambulatory infusion pump assembly (or“pump assembly”) 200, and one of the baseplate assemblies 300, 301 and302. The baseplate assemblies 300, 301 and 302 each include an energysupply 400 and a respective baseplate 500, 501 and 502. The baseplates500, 501 and 502 are configured to be attached to the pump assembly 200and, to that end, each includes a plate member 510, a pair of opposingconnectors 512, and a hook 514.

The baseplates 500, 501 and 502 are also configured for different modesof system operation. Baseplate 500 is a body adherable baseplate thatmay be used in conjunction with a cannula 600 that is directly connectedto the cartridge 100 so that the system 10 may be deployed as a“patch-pump” by securing the baseplate to the patient's skin (FIG. 2A).Baseplate 501 is configured to connect the cartridge 100 to an infusionset 503 so that the system 11 may be deployed as a “pocket pump,” a“belt-worn pump” or some other wearable pump (FIG. 2B). Baseplate 502 isa medicament non-delivery baseplate that may be used to seal thecartridge 100 during periods of non-use (e.g., by way of plug 504),thereby defining a non-use system 12. In other words, using the samepump assembly (e.g., pump assembly 200), the user may configure thesystem for use as “pocket pump” or a “patch pump” by simply selectingthe appropriate baseplate assembly and attaching the baseplate assemblyto the pump assembly. The user may also switch from one configuration toanother, by simply removing one baseplate assembly and replacing it withanother baseplate assembly. The baseplate assemblies may also beconfigured for different medicaments, such as different medicamentconcentrations, and/or different medicament amounts.

In some instances, the cartridge 100 may be detached from a baseplateassembly and inserted into the pump assembly 200 prior to the baseplateassembly being secured to the pump assembly. In other instances, thecartridge 100 may be secured to, integral with or otherwise a part of abaseplate assembly so that the cartridge will be inserted into the pumpassembly 200 as the baseplate assembly is secured to the pump assembly.For example, the baseplate assembly 300 includes a cartridge 100 that issecured to the baseplate 500 (e.g., with adhesive) in exemplary system10, while the cartridge 100 and baseplate assembly 301 are separatestructures in exemplary system 11. Baseplate 502 is employed in thoseinstances where the cartridge and baseplate are detached from oneanother.

It should also be noted here that, in addition to the baseplate,cartridge, and energy supply, some baseplate assemblies may also includethe cannula 600 as well as an inserter 800 for inserting the cannula.Other baseplate assemblies with various combinations of these components(e.g. a baseplate and a cartridge that is either secured to thebaseplate or separated therefrom) may also be provided. The baseplateassembly components may be integrated together into a single packagethat can be delivered to the user, as shown, for instance, as baseplateassembly 300′ in FIG. 17. In other implementations, some or all of thebaseplate assembly components may be provided to the user separately, asuser-replaceable parts.

Whether configured as a “pocket pump” or a “patch pump,” the system maybe configured to provide basal delivery of medicament in accordance witha delivery profile provided by a physician by way of a clinician'sprogramming unit. For example, the system may include a program thatstores a number of delivery profiles (e.g., delivery profiles associatedwith a 24-hour delivery cycle, delivery profiles for particularsituations such as sleep or illness, and the like). Each deliveryprofile specifies multiple doses (or pump “operations”) over time, e.g.,a particular number of doses at particular times or a particular numberof doses per unit time. In some implementations, a dose may be thevolume associated with the minimum controllable displacement of acartridge plunger. The system may also be configured to provide bolusdelivery in response to an instruction from a patient remote control. Abolus instruction may come in response to a high glucose levelmeasurement in the case of a diabetic patient, an increase in pain levelin the case of a pain management patient, or some other symptom. Thesystem may also be configured to perform other functions, such as endingmedicament delivery, in response to instructions from a patient remotecontrol.

The present infusion pumps may be used in conjunction with a widevariety of remote controls. Such remote controls may be used to, forexample, allow the user to transmit instructions to the pump assembly orfacilitate communication between the pump assembly and the user (e.g.,an alarm condition message or other message concerning the conditions ofthe pump assembly). An exemplary remote control 1000 (FIG. 14) may beconfigured to facilitate one, some or all of the following operations:(1) turning the remote control 1000 on or off, (2) associating (or“assigning”) the remote control 1000 to the pump assembly 200, (3)obtaining status information such as medicament level, battery chargelevel, and/or alarm conditions, (4) silencing the pump assembly alarm,(5) selecting options that may be associated with the pump assemblyalarm such as type of alarm (audible, palpable, and/or visible) andstrength/volume of alarm, (6) connecting the remote control to acomputer to, for example, update remote control or pump assemblyfirmware, load and delete delivery profiles stored in the pump assemblyor remote control, and otherwise reprogram the pump assembly or remotecontrol, (7) selecting medicament options such as medicamentconcentrations, (8) selecting and initiating a stored medicamentdelivery profile, (9) increasing and decreasing medicament dose rate,(10) retracting the plunger pusher from the cartridge to the homeposition, and/or (11) pausing a dispensing operation. A user may pausedelivery in order to remove or replace a patient applied structure(e.g., a baseplate assembly), adjust for a current or anticipated changebody condition (e.g., low glucose, vigorous exercise), follow aphysician's suggestion, or disconnect the pump assembly from the bodyfor any other reason.

The exemplary remote control 1000 may be configured to generate anindicator, based on information from a controller for pump assembly 200,that is indicative of the amount of time remaining in the currentdispensing program and/or the amount of time until the next baseplateassembly replacement and/or the amount of time until the pump assemblybattery requires recharging. The indicator may be audible, visible,palpable or combinations thereof. A time remaining indicator may beuseful for a variety of reasons. For example, knowledge of the timeremaining prior to next baseplate assembly replacement allows thepatient to determine, based at least in part on the current time of dayand upcoming events (e.g., travel or sleep), whether or not it would bemore convenient to replace the baseplate assembly at a time prior to theend of the dispensing program.

The system may also be provided with baseplate assemblies configured fordifferent concentrations of medicament, such as different types ofinsulin. For instance, U-100 insulin is a relatively low concentrationinsulin containing 100 international units (IU) of insulin activity per1 ml and, accordingly, a 2 ml cartridge reservoir stores 200 IUs. Onecommon insulin dose is 0.5 IU, which equates to a dispensed volume of 5microliters (μl) of U-100 per dose, 400 doses per 2 ml reservoir, andabout 4.5 days of therapy at the common dosage. However, higherconcentration insulins are commercially available. Humulin® R U-500insulin, which is available from Eli Lilly and Company in Indianapolis,Ind., contains 500 IU/ml. Additionally or alternative, differentbaseplate assemblies may be configured for different medicament fillvolumes, to correspond to the amount of medicament used in the baseplateassembly lifetime. Therefore, a variety of baseplate assemblies can beprovided containing different concentrations and/or amounts ofmedicament, such as various concentrations and/or units of insulin. Inaddition to baseplate assembly packaging and labeling, the differentbaseplate assemblies may include visual cues to differentiate thevarious baseplate assemblies. For instance, baseplate assemblies withdifferent concentrations of medicament or different medicament fillvolumes may use different colors for the cartridge and/or baseplate ofthe baseplate assembly.

When a baseplate assembly is attached to the pump assembly, the pumpassembly may automatically detect the version of baseplate assembly thatwas attached, as described further below. Alternatively, the patient ora clinician may program the pump, such as via a remote control, toindicate the type of baseplate assembly attached. In a manner such asthis, a patient can access a variety of medicaments for use with asingle pump assembly.

As such, parts of the present systems may be considered the reusableparts, while other parts may be considered the disposable parts. In theillustrated embodiments, the pump assembly 200, which includesstructures such as the motor and various mechanical structures, the pumpassembly controller, and a rechargeable battery, is reusable, while thebaseplate assembly, which may include some or all of a baseplate (suchas one of the baseplates 500-502), a cartridge 100, an energy supply400, a cannula 600, and a cannula inserter 800, is disposable. Anotherdisposable baseplate assembly 300′ is shown in FIG. 17.

The exemplary system is, as noted above, a cartridge-based system inthat medicament cartridges 100 (which may or may not be included as partof baseplate assembly 300 or 301) are inserted into the pump assembly200 and later removed from the pump assembly. The cartridges 100 mayalso be, but are not required to be, prefilled and disposable. Prefilledcartridges are advantageous for a variety of reasons. By way of example,but not limitation, some users prefer to avoid cartridge fillingprocedures because they are inconvenient and tend to involve needles.User-based refilling also increases the likelihood that air bubbles willbe introduced into the cartridge, while prefilling by the manufacturerof the cartridge and/or the medicament can be accomplished without anysubstantial introduction of air bubbles using, for example, a vacuumfilling procedure.

Referring to FIG. 10, the exemplary medicament cartridge 100 may includea barrel 102 that defines a medicament reservoir 104, a plunger 106, anda manifold 108. The manifold 108, which may include a through-bore 116,may be used to connect the reservoir to, for example, cannulas andbaseplate structures. The plunger 106 moves within the cartridge to varythe volume of medicament within the reservoir. The cartridge 100 mayalso be provided with a plug 110 that prevents leakage from a prefilledreservoir (e.g., prefilled in a vacuum with U-500 insulin) duringpackaging, shipping, storage and handling, and can be manually removedby the user.

At least some of the exemplary implementations may employ pressure datain various contexts. For example, a pressure sensor may be used todetect occlusions that are impeding, or completely preventing,medicament flow. To that end, a medicament cartridge may include some orall of the pressure sensor itself. The pressure sensor may also be usedto detect the presence of a cartridge in the pump assembly, as is alsodescribed below.

Briefly, the exemplary pump assembly 200 may include an external housing(“housing”), which is generally represented by reference numeral 202 inFIG. 3, and a pump module that is located within the housing, and istherefore not shown. Other structures that may be carried within thehousing 202 include, but are not limited to a rechargeable battery, apump assembly controller and associated circuitry 237 (FIG. 6), and analarm. When the baseplate assembly is attached to the pump assembly andmedicament cartridge 100 is in operational position within the pumpassembly 200, the cartridge plunger 106 will be proximate to and facinga plunger pusher 250 of the pump module (see FIG. 10). A drive mechanismof the pump module may then drive the plunger pusher relative to thecartridge plunger to controllably and precisely dispense medicament fromthe cartridge reservoir.

As noted above, the exemplary pump assembly 200 may include an alarmthat is carried within the housing 202. The alarm may be audible (e.g.,a buzzer), palpable (e.g., a vibrator), visible (e.g., an LED with aportion that extends through the housing 202) and/or any combinationthereof. A number of conditions may result in alarm activation in theexemplary embodiments. For example, alarm conditions include, but arenot limited to, low or dead battery, occlusion, low or empty reservoir,hardware self-test, firmware error, absence of a baseplate, devicefall-off, baseplate/pump assembly disconnection, battery chargeover-temperature, telemetry fault, motor error, unable to find plunger,and/or charging faults.

Referring to FIGS. 3-4, the housing 202 has a top portion 206 and abottom portion 208. The top portion 206, which includes two side walls210, two end walls 212, a top wall 214 and rounded corners therebetween,generally defines the internal volume in which the pump module and otherpump assembly components are carried, as well as the overall volume ofthe pump assembly 200. The bottom portion 208 includes a bottom wall216, which functions as a cover for most of the internal volume. Theouter surface of the top wall 214 defines the “top face” or “topsurface” of the housing 202, and the outer surface of the bottom wall216 defines the “bottom face” or “bottom surface” of the housing.

There is a cartridge insertion opening 218 in the bottom wall 216through which the cartridge 100 is inserted into the cartridge receivingarea 220 when baseplate assembly 300 is attached to pump assembly 200.Bottom wall 216 also includes a baseplate energy supply receiving area(or “recess”) 222 into which the energy supply 400 projects when abaseplate assembly (e.g., baseplate assembly 300) is attached to pumpassembly 200. This arrangement facilitates the transfer of energy fromthe baseplate energy supply 400 to the rechargeable battery 238, asdescribed below.

The top wall 214 of the housing 202 may be provided with one or moreopenings. For example, an inserter opening 224 may be provided in thehousing top wall 214 to enable access for an inserter 800 or 800′. Suchaccess may be required for a cannula insertion process, such as thatdescribed below with reference to FIGS. 10-13.

The top wall 214 of the housing 202 may also be provided with acartridge opening 226 for the top of cartridge 100. The inserter opening224 and cartridge opening 226 are merged into a single opening in theillustrated embodiment. Such openings may be separate in otherembodiments. Cartridge opening 226 facilitates observation of themedicament and plunger within a cartridge formed from transparentmaterial. Additionally, in the illustrated embodiment, the pump assembly200 is configured (i.e., sized, shaped, etc.) such that a portion of theassociated cartridge (e.g., cartridge 100) may protrude through thecartridge opening 226 when the baseplate assembly is in place and thecartridge is in the cartridge receiving area 220. For example, therelative configurations of the baseplate assembly 300, cartridge 100 andpump assembly 200 may be such that the cartridge body protrudes slightly(e.g., about 0.40-1.00 mm, or five percent of the reservoir volume)through the opening 226 in the housing top wall 214, as is illustratedin FIG. 5. The bulk of the cartridge body will, however, be locatedbelow the inner surface of the top wall 214. The length of the cartridgeopening 226 is substantially equal to the length of the cartridgereservoir, with appropriate clearance, while the width is somewhat lessthan the diameter of the cartridge. For example, the width of theopening 226 may be about 60 to 90% of the diameter and is about 83% inthe illustrated implementation. In other implementations, the cartridgeopening 226 may be eliminated and replaced by a protrusion that coversthe cartridge and is part of the housing top wall 216.

A plurality of electrical contacts 228, 230 and 232 may extend through(or be carried on) the housing bottom portion 208, as is illustrated inFIG. 4. As discussed in greater detail below, two of the contacts (e.g.,contacts 228 and 230) may be used to electrically connect the pumpassembly 200 to a battery recharger (e.g., charger 700 in FIG. 6) andall of the contacts, at least in some implementations, may be used bythe pump assembly during a baseplate identification procedure describedbelow.

With respect to dimensions, some embodiments of the exemplary housing202 may have the following dimensions: length dimensions of 42 mm+/−1.0,42 mm+/−0.10, 40+/−1.0 mm, 40+/−0.10 mm or 40+/−5.0 mm; width dimensionsof 34 mm+/−1.0, 34 mm+/−0.10 mm, 32 mm+/−1.0 mm, 32 mm+/−0.10 mm or 32mm+/−5 mm; overall thickness or height dimensions of 9 mm+/−1.0 mm or 9mm+/−0.10 mm; and wall thickness dimensions on the order of 1.0mm+/−0.10 mm. Suitable housing materials include, but are not limitedto, plastic or other materials having a modulus of elasticity of 0.2-1.0million psi.

As mentioned above, pressure sensors may be provided to, among otherthings, detect occlusions in a cannula or infusion set tube. Occlusionsmay occur for any number of reasons including, but not limited to,cannula kinks caused by movement of the pump assembly relative to adeployed cannula, kinks in the infusion set tube, or granuloma formationat the outlet end of a cannula. The structures that are used to sensepressure may also be used to, for example, sense baseplate assemblyattachment, medicament cartridge presence, and/or alignment within apump assembly. In at least some implementations, one portion of thepressure sensor may be part of the medicament cartridge and anotherportion of the pressure sensor may be part of the pump assembly. Otherexemplary detectable structure arrangements include, but are not limitedto, a magnetically permeable structure carried on a diaphragm andmovable relative to a coil; and an optical element carried on adiaphragm and movable relative to an optical sensor; and an electricalconductor carried on a diaphragm and movable relative to a pair ofswitch contacts. It should also be noted that, with respect to theimplementations that include a pressure sensor, the present inventionsare not limited to pressure sensor arrangements that include adiaphragm, or to pressure sensor arrangements that include a cartridgeportion and a pump assembly portion. For example, a medicament cartridgemay include a pressure sensor that communicates with the pump assemblyby way of electrical contacts.

The battery that drives the motor may be a rechargeable battery, such asa rechargeable lithium polymer battery or a rechargeable lithium ionbattery. At least some implementations will employ a rechargeablebattery having a fully charged, open circuit voltage of generally about3.7 Volts, or between about 3.0-4.24 Volts. One advantage of lithiumpolymer and lithium ion batteries is that they can be recharged quickly,have high energy density, and have desirable linear decay thatfacilitates accurate charge state indication.

Turning to FIG. 6, the exemplary rechargeable battery 238 may be carriedwithin the pump assembly housing 202. Additionally, because the battery238 is rechargeable, e.g., via external recharging contacts 228 and 230or the baseplate energy supply 400, the exemplary housing 202 does notinclude a door or a cover to provided access to the battery, and theexemplary housing may be sealed (i.e., it cannot be opened withoutdamage thereto).

One example of a battery recharger, which is generally represented byreference numeral 700 in FIG. 6, includes recharging circuitry 702(e.g., a controller and power circuitry) within a housing 704. The topportion of the recharger housing 704 may include a plate 706, a pair ofopposing connectors 712, a hook 714, and electrical contacts 228R and230R. Power and data connectors 716 and 718 may also be provided. Therespective configurations of the pump assembly 200 and battery recharger700 are such that, when the pump assembly is placed on the plate 706with an end wall 212 abutting the hook 714, the pump assembly rechargecontacts 228 and 230 will be electrically connected to the rechargercontacts 228R and 230R.

It should be noted here that the present pump assemblies and batteryrechargers are not limited to those which make a direct electricalconnection through the use of electrical contacts. By way of example,but not limitation, inductive coupling may be employed.

In addition or as an alternative to the above, rechargeable battery 238may be recharged by the baseplate energy supply 400 carried on baseplate500-502 (see FIG. 1). Referring to FIG. 15, the exemplary energy supply400 includes a housing 402 and an energy storage device 404 within thehousing. Any suitable energy storage device may be employed. Exemplaryenergy storage devices include, but are not limited to, primary cellbatteries, fuel cells and capacitive storage devices. Exemplary primarycells include alkaline batteries and Zinc-air batteries, including thosein the form of small button cells of the type commonly used in hearingaids. Such batteries are sometimes referred to as “disposable”batteries. The energy supply also includes a pair of flexible electricalcontacts 406 and 408 that are respectively connected to the anode andcathode of the energy storage device 404. A seal 410, such as an o-ringseal, extends around the base of the energy supply housing 402.

As noted above, the baseplate energy supply 400 projects into thebaseplate energy supply receiving area 222 when a baseplate assembly(e.g., baseplate assembly 300) is attached to the pump assembly 200. Tothat end, the receiving area 222 is defined by a side wall 260 and anend wall 262 that are formed in the bottom wall 216 of the housing 202.A pair of electrical contacts, such as the illustrated annular contact264 and circular contact 266, are located on the end wall 262. Thecontacts 264 and 266 are connected to the circuitry 237. The respectiveconfigurations of the receiving area 222 and the baseplate energy supply400 are such that the energy supply contacts 408 and 408 will engage thereceiving area contacts 264 and 266, and the seal 410 will engage theside wall 260 to prevent moisture ingress, when the baseplate assembly300 is connected to the pump assembly 200.

It should also be noted here that the present inventions are not limitedto the exemplary receiving area 222 and baseplate energy supply 400described above. For example, the baseplate energy supply 400 may beprovided with other types of flexible or otherwise outwardly biasedelectrical contacts. Alternatively, or in addition, the receiving area222 may be provided with flexible or otherwise outwardly biasedelectrical contacts. One or both sets of electrical contacts may also beeliminated. For example, in those instances where the baseplate energystorage device is a button battery, the baseplate energy supply and theinfusion pump energy supply receiving area may be configured such thatcontacts within the receiving area directly contact the anode andcathode cans of the battery. Inductive coupling may be employed in otherimplementations.

At least some implementations will employ an energy storage device 404having a fully charged, open circuit voltage of generally about 1 Volt,or between about 1.0-1.5 Volts.

The energy storage device 404 may be a Zinc-air battery, the advantagesof which include high energy density, small size and wide availability.Zinc-air batteries obtain their energy from the electro-chemicalreaction of oxidizing zinc with oxygen from the air. Therefore, thehousing 402 may be provided with an aperture and a cover that can beused to prevent air from initiating the reaction and activating thebattery. As such, in some embodiments, prior to use, a cover must beremoved from the housing 402. Other primary batteries (e.g., an alkalinebattery) that may be used to recharge rechargeable battery 238 may notrequire removal of a battery cover.

Returning to the above example, the recharging of rechargeable battery238 with baseplate energy supply 400 may use a DC-to-DC converter, forinstance, within circuitry 237 (FIG. 6). The DC-to-DC converter may beused to convert the nominal 1 V from the energy storage device 404 to avoltage that is greater than the voltage of the battery 238, e.g.,greater than a nominal 3.7 V, to recharge the rechargeable battery 238.In some implementations, the recharging process may be controlled by thepump assembly controller, such as by circuitry 237 associated with thepump assembly controller, or by other circuitry (such as dedicatedcircuitry or a DC-to-DC converter semiconductor chip), or somecombination thereof. In such implementations, the pump assemblycontroller (or processor circuitry, etc.) may monitor the primarybattery voltage and actively control the recharging process, such aswhen to commence or cease charging. In other embodiments, the rechargeprocess and/or primary battery voltage may not be controlled ormonitored, and the recharging proceeds until the primary battery isexhausted.

Given the relatively close proximity of the rechargeable battery 238 tothe medicament cartridge 100, heat from the battery 238 could possiblyincrease the temperature of the medicament during recharging, especiallyduring rapid recharging. The medicament temperature may be relevant tocertain medicaments such as insulin, for example, which can be damagedand have its viability become undefined at about 37° C. Accordingly, atemperature sensor 239 (e.g., a thermistor or thermocouple) may also becarried within the pump assembly housing 202 in such a manner that thetemperature sensor can sense the temperature of the medicament in thecartridge 100 (or a temperature that is at least representativethereof). For example, the temperature sensor 239 may be carried on thecircuit board associated with the exemplary pump assembly controller.Temperature sensing apparatus, such as a heat pipe that extends to thereservoir (not shown), may also be included on some cartridgeimplementations. The temperature information may be provided to the pumpassembly controller, or to other circuitry such as in recharger 700, oranother controller (collectively referred to as the “rechargecontroller”), to modulate the battery recharging process as a functionof temperature sensed by temperature sensor 239.

Modulation of the recharging process may be accomplished by, forexample, selectively increasing or decreasing the rate at which thebattery 238 is recharged (e.g., by controlling current) as a function ofsensed temperature. For example, and referring to FIG. 7, the modulationprocess may be designed to perform temperature control in a manner thatprevents the sensed temperature from overshooting the predeterminedmaximum temperature (T_(MAX)) as shown by the dashed lines. To that end,as temperature reaches a modulation temperature (T_(MOD)) below themaximum temperature T_(MAX), the recharging rate is reduced to keep thetemperature at or below the maximum temperature T_(MAX).

It should also be noted that it may be difficult for the battery 238 toprovide enough current if the temperature within the pump housing 202 islow. The temperature sensor 239 may, therefore, be used to monitortemperature during operation of the pump assembly 200. An alarm may beactuated by the recharge controller if the temperature is too low.

In at least some implementations, the recharge controller may beconfigured to identify and/or prevent charging faults, such as batteryovercharge that can cause the battery to swell, vent and otherwisestress other components within the pump assembly.

With respect to the amount of time until the rechargeable battery 238requires recharging, the pump assembly may be provided with a batterymanagement chip (or other suitable battery management apparatus) thatdetermines when recharging is necessary. For example, recharging may benecessary when the battery voltage is reduced from the fully chargedvoltage to a predetermined voltage that is less than the fully chargedvoltage. The amount of time remaining may be estimated by the batterymanagement apparatus based on factors such as battery age, batterytemperature, and the dispensing program. The battery managementapparatus may be part of, or operably connected to, the pump assemblycontroller. The controller is configured to generate a signal indicativeof the amount of time remaining until the battery will requirerecharging.

Alternatively, and in particular when using the baseplate energy supply400 with the baseplate assembly, the rechargeable battery 238 isrecharged to full capacity each time a new baseplate assembly isattached to the pump assembly. In other words, when the patient requiresor desires a new medicament cartridge, the new baseplate assembly willinclude the baseplate energy supply 400, which will recharge therechargeable battery. The rechargeable battery 238, under normaloperation (e.g. with no battery failure or discharge problems), willmaintain a charge longer than the time it takes to empty cartridge 100.As such, if the system is operating as usual, the patient will notreceive a message that rechargeable battery 238 needs to be recharged.

As noted above, and as illustrated for example in FIGS. 1, 2A and 2B,the present infusion systems may include any one of a variety ofdifferent baseplate assemblies (shown without cartridge 100 and inserter800 for ease of differentiation) in combination with a pump assembly(e.g., pump assembly 200). As an example, FIG. 17 illustrates anexemplary baseplate assembly 300′ that includes baseplate 500′, inserter800′, cartridge 100′, and baseplate energy supply 400′. Each baseplateassembly may be configured for a different mode of system operation. Forinstance, baseplate 500 is a body adherable baseplate that may be usedin conjunction with a cannula such as cannula 600 connected to thecartridge 100 so the system may be deployed as a “patch pump.” Baseplate501 is configured to connect the cartridge 100 to an infusion set 503 sothat the system may be deployed as a “pocket pump,” a “belt-worn pump”or some other wearable pump. Baseplate 502 is a medicament non-deliverybaseplate that includes a plug 504 which may be used to seal thecartridge 100 during periods of non-use.

As also described above, the system may be provided with baseplateassemblies configured for different types or concentrations ofmedicament, such as different insulin concentrations. Additionally oralternatively, a variety of baseplate assemblies may be provided withdifferent medicament fill volumes, to correspond to the amount ofmedicament used during the baseplate assembly lifetime. Therefore, anassortment of baseplate assemblies is possible, containing differenttypes, concentrations and/or amounts of medicament, such as variousconcentrations and/or units of insulin. These different baseplateassemblies may be distinguished by packaging, labeling, or other cuessuch as different colors for the cartridges and/or baseplates of thevarious baseplate assemblies.

Additionally, and as discussed below, pump assembly 200 and baseplateassemblies 300-302 may be respectively configured such that a pumpassembly can determine which one of a variety of baseplate assemblies isattached to the pump assembly and then prepare to proceed in accordancewith the operational mode associated with that baseplate assembly. Also,although the exemplary baseplate assemblies are described herein in thecontext of the exemplary cartridge 100 and the exemplary pump assembly200, the present baseplates and baseplate assemblies may be used inconjunction with other cartridges, cartridge-based pumps, and pumps thatare not cartridge-based.

Exemplary baseplates for use with the baseplate assemblies of thepresent inventions, exemplary cannula designs, fluidic connectionbetween a medicament cartridge and the cannula, cooperation between thecannula and baseplate assemblies, for instance, to prevent axialmovement of the cannula relative to the baseplate and patient,attachment of an infusion set to the cartridge of the baseplateassembly, configurations and uses of a non-delivery baseplate,arrangements and structures for attaching baseplate and pump assemblies,skin adhesive designs, occlusion sensors, and various inserters may beas described in U.S. patent application Ser. No. 12/890,207, filed Sep.24, 2010.

The dimensions of the baseplate assembly may correspond to those of theassociated pump assembly. In the context of the exemplary pump assembly200 described above, the plate member may be 1 mm thick, withlength/width relationships such as 42 mm×34 mm, 40 mm×32 mm, and/or39.0-43.0 mm×31.0-35.0 mm.

It should also be noted that the present inventions include kits whichcontain various combinations of baseplates, at least two of thebaseplates being different. Additionally or alternatively, kits or otherpackages may include various baseplate assembly components, such asmedicament cartridges and/or cannula inserter, as user replacements.Kits may also include a pump assembly. The baseplate assemblies in suchkits may also include the detection instrumentalities discussed below.The components of the present kits (e.g., combination of variousbaseplate assemblies and/or components) may be stored in a commonpackage, with individual packages for each component if necessary, andprovided to the user in the common package. Other components that may beprovided in such kits include, but are not limited to, inserters thatare preloaded with a cannula and cleaning swabs. A recharger may also beprovided in a kit that includes a pump assembly.

It should be noted here that, but for the issue of priming, thedispensing procedures associated with an infusion system “patch pump”configuration, which may include a pump assembly 200 and a baseplateassembly 300, are substantially the same as the dispensing proceduresassociated with a “pocket pump” configuration, which may include a pumpassembly 200 and a baseplate assembly 301 (see FIG. 1). With a “patchpump” configuration, priming is not necessary because the volume of theassociated cannula will be very small and there is a direct connectionbetween the cannula and the medicament cartridge. Priming is, however,required to fill the infusion set tube (FIG. 1) in a “pocket pump”configuration prior to the onset of medicament delivery. For instance,20-30 μl may be required to fill the entire infusion set tube and,accordingly, the priming procedure may involve the rapid delivery of10-15 IUs of U-500 insulin to the tube. The present inventors havedetermined that it would be advantageous to prevent users frominitiating a priming procedure when the system is in the “patch pump”configuration, with a cannula positioned to deliver medicamentessentially directly from the medicament cartridge to the patient,because rapidly delivering 10-15 IUs of insulin to the patient couldadversely affect patient health.

To prevent such undesirable outcomes, and for user convenience in othersituations involving the choice between a variety of baseplateassemblies, at least some of the present baseplate assemblies may beprovided with a baseplate identification device and at least some of thepresent pump assemblies may be provided with structure that cooperatewith a baseplate identification device in such a manner that the pumpassembly controller can make a “baseplate type” determination. Forexample, the baseplate identification devices may be carried by thebaseplates and may be detectable by the pump assembly as well asdistinguishable from one another. Once the “baseplate type”determination is made (e.g., baseplate assembly 300 versus baseplateassembly 301), the pump assembly will proceed in a manner, or mode ofoperation, that is appropriate for the attached baseplate assembly. Forexample, if baseplate assembly 300 is detected, the pump assemblycontroller will not including priming as part of the delivery processand, in some implementations, will prevent the user from manuallyimplementing a priming procedure. If, on the other hand, baseplateassembly 301 is detected, then the delivery process may includeappropriate priming of the infusion set tube.

In other embodiments, the identification process may additionally oralternatively distinguish between baseplate assemblies with cartridgescontaining different medicaments, different concentrations of amedicament, and/or varying amount of medicaments. For instance, if thepump assembly determines that the baseplate assembly is carrying a highconcentration medicament, such as U-500 insulin, it can appropriatelyadjust the dispensing program. If, on the other hand the pump assemblysenses a baseplate assembly with a lower concentration medicament, suchas U-100 or U-200 insulin, it can provide a proper dispensing programfor that concentration. As another example, the pump assembly may detecta baseplate assembly with a certain amount of medicament, and makeappropriate adjustments to, for instance, display the medicament leveland/or warn the patient when the medicament level is low.

A wide variety of baseplate identification instrumentalities andidentification methodologies may be employed, and the present inventionsare not limited to any particular instrumentalities and methodologies.Various illustrative examples of such instrumentalities andidentification methodologies are described in U.S. patent applicationSer. No. 12/890,207, filed Sep. 24, 2010. In one such example, baseplateassemblies 300, 301 and 302 may have respective identification devices582-0, 582-1 and 582-2 (see FIG. 1), each of which includes a pair ofelectrical or optical contacts or the like that align and electricallyor optically couple (or the like) to a respective two of the threeelectrical or optical contacts 228, 230 and 232 or the like associatedwith the pump assembly (FIG. 4) when a baseplate assembly is secured tothe pump assembly. For instance, the pump assembly controller may causevoltage to be applied across the pump assembly electrical contacts 228,230 and 232 and may measure resistance (or another suitable variable)between contact pairs 228/230, 230/232 and 228/232. The pump assemblycontroller may store information which indicates the resistance levelsthat correspond to particular baseplate assemblies, and use theresistance measurement to identify the attached baseplate assembly. Inone of the other examples described in U.S. patent application Ser. No.12/890,207, a wide range of resistance values are possible by employinga variety of resistors, two contacts on the baseplate assembly, and twocontacts on the pump assembly.

At the most basic level, use of the exemplary infusion pump system 10(or 11, etc.) illustrated in FIG. 1 involves obtaining a new baseplateassembly 300 (or 301, etc.), connecting the baseplate assembly to thepump assembly, peeling the cover from the baseplate adhesive layer,gaining subcutaneous access, and initiating a medicament deliveryoperation. In some instances, use may involve additional steps such asremoving the cover from baseplate energy supply 400 (if a Zinc-airbattery is employed) or pulling the pull-before-use-plug 110 fromcartridge 100 of the baseplate assembly, if necessary. Various aspectsof the basic operation of the present systems are described below.Operation of a system does not necessarily require all of the steps eachtime the system is deployed, and the order of some of the steps may bechanged. Operation is also discussed below, in the exemplary context ofthe above-described pump assembly 200 and patch pump baseplate assembly300, through the use of a flow chart (FIG. 8) as well as throughillustrations of the exemplary system itself in various states (FIGS.9-14). The discussion is, however, equally applicable to other patchpump implementations, as well as to pocket pump implementations withminor variations. Also, unless otherwise indicated, the actions anddeterminations performed by the pump assembly 200 are controlled by thepump assembly controller and further references to the controller areomitted in the interest of brevity.

Referring first to FIG. 8, use of the present systems may involveremoval of a baseplate assembly from a pump assembly. This may occur (insome instances automatically) when the medicament cartridge is empty(e.g. when the plunger pusher 250 is at the end of the pusher stroke, asdescribed in more detail in U.S. patent application Ser. No. 12/890,207)(Step S101) and a “replace baseplate assembly” message or alert ispresented (Step S102), or when the pump assembly controller receives auser-initiated “replace baseplate assembly” signal from the remotecontrol 1000 (Step S103). The user may desire to replace a baseplateassembly before the medicament cartridge is empty for a variety ofreasons such as, for example, to accommodate the user's sleep or travelschedule, when the medicament appears cloudy or otherwise exhibits aloss of effectiveness, when a dispensing problem arises, or due to aprescribed change in medicament. Whether automatic or user-initiated,the plunger pusher 250 will be returned to the fully retracted homeposition (Step S104). The user may then obtain a new baseplate assembly(such as baseplate assembly 300 shown in FIG. 1, containing cartridge100, energy supply 400, baseplate 500, cannula 600, and inserter 800, orbaseplate assembly 300′ shown in FIG. 17, containing cartridge 100′,energy supply 400′, baseplate 500′, cannula 600′ (not shown), andinserter 800′) and the remote control 1000 (if not already at hand)(Step S105). The pump assembly 200 and baseplate assembly 300 may thenbe removed from the skin, separated, and the baseplate assembly 300discarded (Steps S106 and S107).

Next, the cover (if present) may be removed from energy supply 400 (StepS108) and the new baseplate assembly 300 may then be attached to thepump assembly 200 (Step S109). The plug 110 may remain in the cartridgethrough-bore 116 for a pusher zeroing procedure described in detail inU.S. patent application Ser. No. 12/890,207 (Step S110). The zeroingprocedure may be user-initiated or may be an automatic aspect of pumpoperation. If the results of the zeroing procedure are negative, thepusher is withdrawn from the cartridge, the baseplate assembly 300 or atleast medicament cartridge 100 is removed and discarded, a new baseplateassembly or cartridge is inserted, and the zeroing procedure is repeated(Steps S111, S112, S113 and S114). Alternatively, if the results of thezeroing procedure are positive, the pusher is withdrawn and the plug 110may be removed (FIG. 10) (Step S115).

The user may clean the skin surface S onto which the baseplate 500 ofbaseplate assembly 300 will be adhered, and liner 544 may be removed toexpose a baseplate adhesive layer 542, as illustrated in FIGS. 9 and 10(Steps S116 and S117). Also shown in FIG. 10 is an exemplary cannulainserter 800, with cannula 600 in its initial position, prior toinsertion. The inserter 800 may include a movable member 802 within ahousing 804, and a trigger-type actuator 806 that acts on the movablemember. The exemplary actuator 806 may have a rotatable or pressabletrigger 808 and a compressed spring or other biasing device 810. Atrocar 812 is carried on the movable member 802. A cannula 600 ispre-mounted on the trocar 812 such that the sharp distal end of thetrocar extends beyond the cannula tube 612. The inserter 800 may also beconfigured to withdraw the trocar back into the housing 804 after thecannula is deployed.

In other embodiments, the initial position of cannula 600 is at leastpartly within through-bore 116, such that plug 110 is unnecessary. Whencannula 600 is initially positioned within through-bore 116, it providesa seal against the medicament outlet 117 of the cartridge 100. As such,plug 110 may be omitted from these embodiments. In these embodiments,the sharp distal end of trocar 812 is entirely within through-bore 116while in the initial position, prior to cannula deployment, to preventaccidental contact by the user. In addition, with cannula 600 in thislower initial position, cannula inserter 800 may be modified to notextend as far above cartridge 100 as in FIG. 10 (see, for instance, FIG.17), while retaining the above-described or similar components tosimilarly insert cannula 600 into operating position, as describedbelow. Thus, these embodiments may remove the need for plug 110 whilemaking baseplate assembly 300 more compact and retaining all of itsother capabilities.

Turning to FIG. 11, the unit consisting of the pump assembly 200,baseplate assembly 300 (including cartridge 100, baseplate 500, energysupply 400, cannula 600, and inserter 800) may be adhered to the skinsurface S (Step S118). The inserter actuator 806 may then be actuated(FIG. 12) such as by pressing or by rotating a trigger 808, therebyallowing spring 810 to drive movable member 802 towards the patient(Step S119). At the end of the movable member stroke, the proximalportion of cannula 600 will be properly seated in the cartridgethrough-bore 116, and the distal end of cannula 600 will besubcutaneously deployed. The inserter 800 may then be removed (FIG. 13,Step S120).

In some implementations, the pump assembly may be provided withstructure (not shown) that performs the function of determining whetheror not the cannula is properly inserted (Step S121). If the cannula isnot properly inserted, an error message will be provided to the user(Step S122).

Finally, as shown in FIG. 14, the remote control 1000 may be used toinitiate a particular medicament delivery operation (Step S123). Thedelivery operation may follow a predetermined delivery profile (e.g. aparticular basal rate, a series of time-spaced bolus deliveries, or somecombination thereof) that is equated to motor rotations, at particularrates and times, required to deliver medicament in accordance with theprofile. The profile may be input by the user with the remote control1000 and stored by the pump assembly controller. For example, the remotecontrol may store a number of different delivery profiles and bolusdeliveries from which the patient can choose. Such profiles maycorrespond to, for example and depending on the medicament, days wherevigorous exercise is expected, days where it is not, incidences ofincreased pain, etc. Alternatively, or in addition, the profile storedin the pump assembly controller may be set by a clinician's programmingunit. In such a case, a remote control may not be needed to initiate,e.g., basal delivery.

The discussion above is also applicable to use of the “pocket pump”system 11. Minor variations in the above-described procedure include,for example, use of baseplate assembly 301 with baseplate 501, deployingthe infusion set 503 instead of a cannula, and priming of the infusionset tube.

Another exemplary ambulatory infusion system is generally represented byreference numeral 10′ in FIG. 17. The exemplary infusion system 10′ isessentially identical to infusion system 10 and similar elements arerepresented by similar reference numerals. To that end, the pumpassembly 200′ includes a housing 202′, with an inserter opening 224′ andcartridge opening 226′, and the other internal components describedabove. The baseplate assembly 300′ includes a baseplate 500′, an energysupply 400′, a medicament cartridge 100′ (with a manifold) and aninserter 800′ (with a cannula) that are attached to one another in themanner shown. The inserter opening 224′ is configured to permit passageof the inserter 800′ when the pump assembly 200′ is placed overbaseplate assembly 300′. After the pump assembly 200′ and cartridgeassembly 300′ are secured to one another, the cannula may be deployedand the inserter 800′ removed from the baseplate assembly 300′.

Various methodologies are presented here in the context of the exemplarystructures described in the preceding sections, and illustrated in FIGS.1-17, for the purpose of explanation only. Although the presentmethodologies may employ the structures described above, they are notlimited thereto. Additionally, the alarms, reports and othernotifications associated with the methodologies described below may beprovided in audible, visible and/or tactile form. A pump assembly mayprovide audible, visible and/or tactile notifications. A remote controlmay also provide audible, visible and/or tactile notifications as analternative to, or in addition to, any notifications provided by a pumpassembly. Additionally, embodiments of the present inventions mayincorporate any one, combinations of less than all, or all of themethodologies or devices referenced above.

Although the inventions disclosed herein have been described in terms ofthe preferred embodiments above, numerous modifications and/or additionsto the above-described preferred embodiments would be readily apparentto one skilled in the art. It is intended that the scope of the presentinventions extends to all such modifications and/or additions and thatthe scope of the present inventions is limited solely by the claims setforth below or later added.

Finally, with respect to terminology that may be used herein, whether inthe description or the claims, the following should be noted. The terms“comprising,” “including,” “carrying,” “having,” “containing,”“involving,” and the like are open-ended and mean “including but notlimited to.” Ordinal terms such as “first”, “second”, “third,” do not,in and of themselves, connote any priority, precedence, or order of oneelement over another or temporal order in which steps of a method areperformed. Instead, such terms are merely labels to distinguish oneelement having a certain name from another element having a same name(but for the ordinal term) to distinguish the elements. “And/or” meansthat the listed items are alternatives, but the alternatives alsoinclude any combination of the listed items. The terms “approximately,”“about,” “substantially” and “generally” allow for a certain amount ofvariation from any exact dimensions, measurements, and arrangements, andshould be understood within the context of the description and operationof the invention as disclosed herein. Terms such as “top,” “bottom,”“above,” and “below” are terms of convenience that denote the spatialrelationships of parts relative to each other rather than to anyspecific spatial or gravitational orientation. Thus, the terms areintended to encompass an assembly of component parts regardless ofwhether the assembly is oriented in the particular orientation shown inthe drawings and described in the specification, upside down from thatorientation, or any other rotational variation therefrom.

1-12. (canceled)
 13. A method, comprising the step of: securing abaseplate assembly with a baseplate energy supply to an infusion pumpassembly with a rechargeable battery such that energy from the baseplateenergy supply is transferred to the rechargeable battery.
 14. A methodas claimed in claim 13, wherein the baseplate assembly includes amedicament cartridge; and the step of securing comprises securing thebaseplate assembly to the infusion pump assembly such that themedicament cartridge is inserted into the infusion pump assembly andenergy from the baseplate energy supply is transferred to therechargeable battery.
 15. A method as claimed in claim 13, wherein thebaseplate energy supply includes an energy storage device.
 16. A methodas claimed in claim 13, wherein the energy storage device comprises aprimary cell battery.
 17. An infusion pump system, comprising: aninfusion pump assembly including a housing and a plunger pusher withinthe housing; and a baseplate assembly including a baseplate and amedicament cartridge, including a barrel defining a reservoir and aplunger movable within the barrel, on the baseplate; wherein theinfusion pump assembly and the baseplate assembly are configured to beattached to one another in such a manner that the plunger pusher will bealigned with the plunger.
 18. An infusion pump system as claimed inclaim 17, wherein the infusion pump assembly includes a rechargeablebattery; the baseplate assembly includes a baseplate energy supply; andthe infusion pump assembly and the baseplate assembly are configured tobe attached to one another in such a manner that energy from thebaseplate energy supply is transferred to the rechargeable battery. 19.An infusion pump system as claimed in claim 18, wherein the infusionpump housing includes a recess configured to receive the baseplateenergy supply; the baseplate energy supply projects outwardly from thebaseplate; and the infusion pump housing recess and baseplate energysupply are respectively positioned such that the baseplate energy supplywill be located at least partially within the pump housing recess whenthe infusion pump assembly and the baseplate assembly are attached toone another.
 20. An infusion pump system as claimed in claim 17, whereinthe baseplate assembly includes a cannula and a cannula inserter.
 21. Aninfusion pump system as claimed in claim 20, wherein the medicamentcartridge includes a through-bore in fluid communication with thereservoir; and the cannula is configured to fit within the through-bore.22. A infusion pump system as claimed in claim 17, further comprising: atemperature sensor positioned to sense a temperature of or approximatingthat of medicament in the reservoir when the baseplate assembly isattached to the housing; and a controller configured to modulaterecharging of the rechargeable battery as a function of temperaturesensed by the temperature sensor.
 23. A baseplate assembly, comprising:a baseplate; a medicament cartridge on the baseplate defining areservoir; a cannula; and a cannula inserter.
 24. A baseplate assemblyas claimed in claim 23, further comprising: a baseplate energy supply onthe baseplate.
 25. An infusion pump system as claimed in claim 23,wherein the cannula is located at least partially within the cannulainserter; and the cannula inserter is removably secured to thecartridge.
 26. An infusion pump system as claimed in claim 23, furthercomprising: a manifold; wherein the cannula is located at leastpartially within the cannula inserter, and the cannula inserter issecured to the manifold.
 27. An infusion pump system as claimed in claim26, wherein the manifold is attached to the medicament cartridge.